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Compliance In Focus
Posted by Jacqui Lingler on Thu, Jun 27, 2013

Clinical Trial Credited for 3-year-old Boy Hearing for the First Time

For those involved in clinical research, whether it is at the site, sponsor, or CRO level, it canClinical Trial Credited for 3 year old Boy Hearing for the First Time be easy to get caught up in the day to day rigor of collecting data; resolving action items all while juggling study staff schedules and fielding patient phone calls.  It is Grayson Clamp that reminds us why we as clinical researchers in the medical device industry do what we do.

Grayson Clamp is a 3-year-old little boy that was born without cochlear nerves, the branch of nerves that collects sound and sends to the brain for hearing. Grayson is the first child in the United States to receive an auditory brain stem implant, following the FDA’s approval of a pediatric clinical trial for the medical device that is already available to adults.  As reported by CNN, UNC Hospitals at Chapel Hill, North Carolina is one site approved to conduct the procedure, previously done mostly in Europe, on 10 approved children in the US. Five of these cases are similar to Grayson, in which, they were born without the cochlear nerves. 

The device includes an external speech processer that breaks up sounds into frequency components and sends information across the skin to an implanted device. The device then stimulates electrodes on the brain’s cochlear nucleus. The electrodes are placed where the cochlear nerve would be, if the child had one.  The initially approved 10 cases will collect safety data to determine if more studies will follow. The biggest risk, as identified by Grayson’s surgeon, Dr. Craig Buchman, occurs during surgery when the device is implanted.

The first words that Grayson heard were “Daddy Loves You”. Doctors, although admit Grayson has a long road, but are confident that he will make a full recovery and will hear and speak as if he were born with the cochlear nerves.

It is easy for clinical researchers to get caught up in day to day activities related to conducting clinical trials and forget about the patients like Grayson. It is because of the hard work, compassion, and innovation in the medical device clinical research industry that Grayson was able to hear his Dad express his love and allow his parents to believe that this opportunity to participate in research is nothing short of a miracle.

Do you have a story to share of medical device research that resembles a story like Grayson’s? Please share it here!

Photo Credit:niclindh

Understanding IRBs



Topics: Clinical Research, Cochlear Nerves, Hearing, Grayson Clamp

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